FDA says Bayer's Trasylol has increased death risk

-Reuters

10/25/2007 - U.S. regulators on Thursday said a trial of Bayer AG's heart surgery drug Trasylol found an increased risk of death from bleeding linked to the treatment.

The U.S. Food and Drug Administration said it was notified that enrollment in the study should be halted because of early findings of an increased risk of death from hemorrhage.

The FDA, in a warning on its Web site posted on Thursday, advised doctors to take the "accumulating data suggesting" an increased mortality risk into account when considering using the drug. The agency said it will revisit the drug's safety, which may include label changes or other regulatory actions.

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